Convertors Sterile Disp. Lap Sponge II
FDA 510(k) K813296 · American Convertors Div., American Pharmaseal
510(k) numberK813296
Submission
- Device name
- Convertors Sterile Disp. Lap Sponge II
- Applicant
- American Convertors Div., American Pharmaseal
Mchenry, IL, US - Received
- November 23, 1981
- Decision date
- December 29, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EFQ – Gauze/Sponge, Internal
- Device class
- Unclassified
Other 510(k)s with product code EFQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K991757 | Non-Absorbable Gauze for External Use, Sterile and Non SterileEFQ · Traditional | Furlong Industries | 08/12/1999SE |
| K991215 | Symtex Gauze Pads (1'S) and Symtex Gauze Sponges Sterile 2'S and Sterile 10'SEFQ · Traditional | Symtex Healthcare Corp. | 06/11/1999SE |
| K990974 | Vitop DressingEFQ · Traditional | Wonder & Bioenergy Hi-Tech America, Inc. | 06/09/1999SE |
| K990584 | Gauze Sponges: Laparotomy Sponge, X-Ray DetectableEFQ · Traditional | Broadline Medical Industries | 04/23/1999SE |
| K984187 | Crosstex Non-Woven SpongesEFQ · Traditional | Crosstex Intl. | 02/18/1999SE |
| K983016 | Gauze, Sponges, Cat # 11-003EFQ · Traditional | Vitalcare Group, Inc. | 02/12/1999SE |
| K983348 | Dynarex Tracheostomy SpongeEFQ · Traditional | Dynarex Corp. | 12/11/1998SE |
| K983450 | Starryshine Gauze SpongeEFQ · Traditional | T.C. Dental Products, Inc. | 11/12/1998SE |
| K982648 | Joan IIEFQ · Traditional | Celanese Acetate Co. | 09/30/1998SE |
| K980791 | Dumex Pak-Its Woven Ribbon PackingEFQ · Traditional | Dumex Medical Surgical Products, Ltd. | 04/29/1998SE |
More from Dumex Medical Surgical Products, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K840957 | Antimicrobial Incise DrapeKKX · Traditional | 06/07/1984SE |
| K832137 | Convertors Flash Sterilizing TrayFSM · Traditional | 08/12/1983SE |
| K830786 | Disimetric Release of Instranetics RadKOA · Traditional | 05/18/1983SE |
| K820994 | Absorb Furn SheetFPY · Traditional | 05/13/1982SE |
| K813419 | Comfort Cushion Dry Burn Pad IIINAB · Traditional | 01/22/1982SE |
| K813078 | Contura Dispos. Surg. Face MaskFXX · Traditional | 12/18/1981SE |
| K812554 | Tomac Sterile Disp. Lap SpongeGDY · Traditional | 09/24/1981SE |
| K802919 | Iso-Bac Instrument WrapFRG · Traditional | 02/02/1981SE |
| K802998 | Patient Care Disposable Infant ShirtsKME · Traditional | 12/22/1980SE |
| K802359 | Disp. Fenestrated Surg. Drape SheetsKKX · Traditional | 10/31/1980SE |
Questions and answers
When was Convertors Sterile Disp. Lap Sponge II cleared by the FDA?
Convertors Sterile Disp. Lap Sponge II (K813296) received a 510(k) decision of Substantially Equivalent on December 29, 1981, 36 days after the submission was received.
What is the product code of K813296?
The FDA product code is EFQ – Gauze/Sponge, Internal, a Unclassified device.